Fluconal® 50: Each tablet contains Fluconazole BP 50 mg.
Fluconal® 150: Each tablet contains Fluconazole BP 150 mg.
Powder for Suspension: After reconstitution each 5 ml suspension contains Fluconazole BP 50 mg.
Fluconal® (Fluconazole) is a triazole antifungal drug which is a highly selective inhibitor of the fungal cell membrane. Fluconal® (Fluconazole) acts by inhibiting the synthesis of ergosterol, a major component of the cell membrane of yeasts and fungi. It has a broad spectrum of activity. Oral administration of Fluconal® (Fluconazole) leads to rapid and almost complete absorption. Administration of the drug with food does not affect absorption.
Fluconal® (Fluconazole) is indicated for the treatment of:
Route of administration:In Adults:Indications:Dosage and Administration:
Vaginal Candidiasis and candidal balanitis.
150 mg as a single dose.
Oropharyngeal Candidiasis.
200 mg on the first day followed by 100 mg once daily for at least 2 weeks.
Esophageal Candidiasis.
200 mg on the first day followed by 100 mg once daily for a minimum of three weeks and for at least two weeks following resolution of symptoms; max. 400 mg daily.
Systemic or invasive candidal infections and Cryptococcal infections.
400 mg on the first day followed by 200 - 400 mg daily; treatment continued according to response (at least 8 weeks for cryptococcal meningitis).
Urinary tract infections and peritonitis.
50-200 mg daily.
Tinea corporis, Tinea cruris, Tinea pedis, Pityriasis versicolor, Dermal candidiasis.
50 mg daily for 2-4 weeks (for up to 6 weeks in tinea pedis); max. duration of treatment 6 weeks.
Onychomycosis.
150 mg weekly for 12 months.
Prevention of fungal infections in immunocompromised patients.
400 mg once daily started from several days before the anticipated onset of neutropenia, and continue for 7 days after the neutrophil count rises above 1000 cells per cu mm.
In Children:
The following dose equivalency scheme should generally provide equivalent exposure in pediatric and adult patients:
Children:Adults:
3 mg/kg.
100 mg.
6 mg/kg.
200 mg.
12 mg/kg.
400 mg.
Based on the prolonged half-life seen in premature newborns (gestational age 26 to 29 weeks), these children, in the first two weeks of life, should receive the same dosage (mg/kg) as in older children, but administered every 72 hours. After the first two weeks, these children should be administered once daily.
Indications:Dosage and Administration:
Oropharyngeal Candidiasis.
6 mg/kg on the first day, followed by 3 mg/kg once daily for at least 2 weeks.
Esophageal Candidiasis.
6 mg/kg on the first day, followed by 3 mg/kg once daily for a minimum of three weeks and for at least two weeks following resolution of symptoms; max. 12 mg/kg/day.
Systemic Candidiasis.
6-12 mg/kg/day.
Cryptococcal infection.
12 mg/kg on the first day followed by 6 mg/kg once daily for 10-12 weeks after the cerebrospinal fluid becomes culture negative; max. 12 mg/kg/day.
Prevention of fungal infections in immunocompromised patients.
3-12 mg/kg/day; max. 400 mg daily.
OR AS DIRECTED BY THE PHYSICIAN.
Pregnancy Category C: Fluconazole may be used in pregnancy only if the potential benefit justifies the possible risk to the fetus. Caution should be taken during lactation.
In patients with renal impairment the dosage schedule should be reduced in accordance with the degree of renal impairment.
Store below 30°C and dry place, protected from light. Keep all medicines out of reach of children.